Related Experiment Video
Updated: Feb 20, 2026
04:46
The Quantification of Injectability by Mechanical Testing
Published on: May 13, 2020
8.7K
Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in
Dietmar Schwab1, Carsten Hofmann1, Nicole Justies1
1Pharma Research and Early Development, Pharmaceutical Sciences, Roc, he Innovation Center, Basel, Switzerland.
Clinical Pharmacology in Drug Development
|February 19, 2026
Summary
This study shows that gantenerumab delivered via autoinjector is bioequivalent to delivery via syringe, offering a more convenient option for subcutaneous administration in Alzheimer's disease research.
Area of Science:
- Neuroscience
- Pharmacology
- Immunology
Background:
- Gantenerumab targets amyloid beta plaques for Alzheimer's disease (AD).
- Pivotal GRADUATE I and II studies did not meet primary endpoints for slowing clinical decline in early AD.
- A high-concentration subcutaneous (SC) formulation was developed for easier administration.
Purpose of the Study:
- To evaluate pharmacokinetics, immunogenicity, and safety of SC gantenerumab.
- To demonstrate bioequivalence (BE) between autoinjector (AI) and disposable syringe (DS) administration.
- To confirm safety profile aligns with known gantenerumab data.
Main Methods:
- A single-dose, parallel-group study in 266 healthy participants.
- 135 participants received 255 mg gantenerumab via AI; 131 via DS.
- Bioequivalence defined by 90% CIs for geometric LS mean ratios of Cmax and AUC within 0.80-1.25.
Main Results:
- Bioequivalence was demonstrated between AI and DS SC administration.
- Geometric LS mean ratios (90% CIs) for Cmax, AUC0-inf, and AUC0-last were 1.078 (1.006, 1.155), 1.053 (0.986, 1.124), and 1.054 (0.992, 1.121), respectively.
- All ratios fell within the 0.80-1.25 bioequivalence range.
Conclusions:
- Subcutaneous administration of gantenerumab via autoinjector is bioequivalent to administration via disposable syringe.
- The autoinjector offers a potentially more convenient SC administration method.
- Safety findings were consistent with the established safety profile of gantenerumab.
More Related Videos
Related Concept Videos
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
170
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
170
01:13Bioequivalence studies: Biowaivers
292
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
292
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
217
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
217
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
165
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
165
01:16Bioequivalence: Overview
2.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
2.1K
01:17Equivalence: In Vitro and In Vivo Bioequivalence
259
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
259